BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME CONNECTING ROD

    MDR report key: 3193339 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04158
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    K993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. THE ITEM WAS NOT RECEIVED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGERY, THE BOLT SHEARED OFF OF THE SYNFRAME CONNECTING ROD. THIS OCCURRED AT THE END OF THE SURGERY AND NO IMPACT TO THE PATIENT WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292030 SYNFRAME CONNECTING ROD LXH SYNTHES GMBH 3314342

    Patients

    Seq Age Sex Outcome Treatment
    1